Key result
Zofenopril cuts 1-year death or CV hospitalization ~37% vs. placebo in high-risk post-MI patients.
Why the study?
The efficacy of zofenopril compared with placebo and other ACE inhibitors in acute myocardial infarction patients with or without cardiovascular risk factors was not fully established.
Does early administration of zofenopril reduce the 1-year combined occurrence of death or cardiovascular hospitalization compared to placebo or other ACE inhibitors in patients with acute myocardial infarction?
Meta-Analysis (n=3,630)
Double-blind
Randomized
Does early administration of zofenopril reduce the 1-year combined occurrence of death or cardiovascular hospitalization compared to placebo or other ACE inhibitors in patients with acute myocardial infarction?
Hazard Ratio: 0.63 (95% CI 0.51–0.78)
p-value: p=0.0001
Early administration of zofenopril after acute myocardial infarction improves 1-year cardiovascular prognosis compared to placebo or other ACE inhibitors, regardless of baseline cardiovascular risk profile.
Zofenopril cuts 1-year CV events post-MI in patients with or without risk factors; extends SMILE evidence favoring it over other ACEIs in higher-risk subgroups.
In the Survival of Myocardial Infarction Long-term Evaluation (SMILE) 1, 3, and 4 studies, early administration of zofenopril in acute myocardial infarction showed to be prognostically beneficial versus placebo or ramipril. The SMILE-2 showed that both zofenopril and lisinopril are safe and showed no significant differences in the incidence of major cardiovascular (CV) complications. In this pooled analysis of individual data of the SMILE studies, we evaluated whether the superior efficacy of zofenopril is maintained also in patients with ≥1 CV risk factor (CV+, n = 2962) as compared to CV- (n = 668). The primary study end point was set to 1-year combined occurrence of death or hospitalization for CV causes. The risk of CV events was significantly reduced with zofenopril versus placebo either in the CV+ (-37%; hazard ratio: 0.63; 95% confidence interval: 0.51-0.78; P = 0.0001) or in the CV- group (-55%; hazard ratio: 0.45; 0.26-0.78; P = 0.004). Also, the other angiotensin-converting enzyme inhibitors reduced the risk of major CV outcomes, though the reduction was not statistically significant versus placebo (CV+: 0.78; 0.58-1.05; P = 0.107; CV-: 0.71; 0.36-1.41; P = 0.334). The benefit was larger in patients treated with zofenopril than other angiotensin-converting enzyme inhibitors, with a statistically significant difference for CV+ (0.79; 0.63-0.99; P = 0.039) versus CV- (0.62; 0.37-1.06; P = 0.081). In conclusion, zofenopril administered to patients after acute myocardial infarction has a positive impact on prognosis, regardless of the patient's CV risk profile.
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Borghi et al. (2016) conducted a meta-analysis in Acute myocardial infarction (n=3,630). Zofenopril vs. Placebo and other ACE inhibitors (ramipril, lisinopril) was evaluated on 1-year combined occurrence of death or hospitalization for cardiovascular causes (HR 0.63, 95% CI 0.51-0.78, p=0.0001). Zofenopril significantly reduced the 1-year risk of death or cardiovascular hospitalization compared to placebo in post-MI patients with ≥1 CV risk factor (HR 0.63; 95% CI 0.51-0.78; P=0.0001).
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